docetaxel

Generic: docetaxel

Labeler: eugia us llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name docetaxel
Generic Name docetaxel
Labeler eugia us llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

docetaxel anhydrous 10 mg/mL

Manufacturer
Eugia US LLC

Identifiers & Regulatory

Product NDC 55150-378
Product ID 55150-378_5e93df13-7250-47d5-9638-0c162252aea4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214575
Listing Expiration 2026-12-31
Marketing Start 2021-06-25

Pharmacologic Class

Established (EPC)
microtubule inhibitor [epc]
Physiologic Effect
microtubule inhibition [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55150378
Hyphenated Format 55150-378

Supplemental Identifiers

RxCUI
1093280 1860619
UPC
0355150378012 0355150379019 0355150380015
UNII
699121PHCA
NUI
N0000175085 N0000175592

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name docetaxel (source: ndc)
Generic Name docetaxel (source: ndc)
Application Number ANDA214575 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-378-01) / 2 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

55150-378-01 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-378-01) / 2 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

docetaxel anhydrous (10 mg/mL)

Linked Drug Pages (1)

Docetaxel ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "5e93df13-7250-47d5-9638-0c162252aea4", "openfda": {"nui": ["N0000175085", "N0000175592"], "upc": ["0355150378012", "0355150379019", "0355150380015"], "unii": ["699121PHCA"], "rxcui": ["1093280", "1860619"], "spl_set_id": ["1263799c-13dc-488b-b158-b834736a4e66"], "pharm_class_pe": ["Microtubule Inhibition [PE]"], "pharm_class_epc": ["Microtubule Inhibitor [EPC]"], "manufacturer_name": ["Eugia US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (55150-378-01)  / 2 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "55150-378-01", "marketing_start_date": "20210625"}], "brand_name": "Docetaxel", "product_id": "55150-378_5e93df13-7250-47d5-9638-0c162252aea4", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Microtubule Inhibition [PE]", "Microtubule Inhibitor [EPC]"], "product_ndc": "55150-378", "generic_name": "Docetaxel", "labeler_name": "Eugia US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Docetaxel", "active_ingredients": [{"name": "DOCETAXEL ANHYDROUS", "strength": "10 mg/mL"}], "application_number": "ANDA214575", "marketing_category": "ANDA", "marketing_start_date": "20210625", "listing_expiration_date": "20261231"}